Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0536-2018 — PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

U.S. FDA — Device Enforcement · United States · 2017-12-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0536-2018
Date of alert
2017-12-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bard Access Systems Inc.
Product category
device
Product type
Devices
Reported risk: Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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